Virus Specific Immune Lymphocytes (Virus-CTL) in the Treatment of Opportunistic Viral Diseases Post Transplantation
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|ClinicalTrials.gov Identifier: NCT03159364|
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Virus Infection EBV Infection Cytomegalovirus Infections Adenovirus Infection BK Virus Infection||Biological: CMV/EBV/ADV/BKV specific CTLs||Phase 1 Phase 2|
Opportunistic infection virus related diseases are major causes of transplant-related morbidity and mortality in immunosuppressed patients, especially in the early post-transplant period. CMV, EBV, adenovirus (ADV), BK virus (BKV) and other viruses after transplantation, which may lead to life-threatening infections.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective without stimulating acute graft-versus-host disease (GVHD) owing to the significantly reduced nonspecific alloreactivity. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of mix opportunistic infection virus peptide cytotoxic T lymphocytes cells in patients.
Primary study objectives: Infusion of autologous or allogenic Virus-CTL to patients by I.V., to evaluate the safety.
Secondary study objectives: To evaluate the antiviral efficacy of IV-infused autologous or allogenic Virus-CTL cells.
Peripheral blood mononuclear cells (PBMC) will be obtained through apheresis. T cells from PBMC will be activated and enriched by dendritic cells with virus specific peptides. Cell preparation time is approximately 12-17 days. Subject will receive infusions of 1x105~4x106 cells/kg body weight of virus-CTL via IV infusion at 4 times. Patients are followed 1 week after the final infusion, monthly for 3 months, and then every 3 months until the trial ends.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II and Multicenter Trial of Virus Specific Immune Lymphocytes (Virus-CTL) in the Treatment of Opportunistic Viral Diseases Post Transplantation|
|Actual Study Start Date :||July 15, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Infusion of CMV/EBV/ADV/BKV specific CTLs
Repetitive CTLs infusion to treat CMV/EBV/ADV/BKV activation and infection
Biological: CMV/EBV/ADV/BKV specific CTLs
Patients will receive approximately 1x10^5~4x10^6 CTLs/kg as a single infusion via IV injection and may receive 1 to 4 additional infusions at intervals of one week.
- Using CTCAE 4 standard to evaluate the level of adverse events after receiving autologous or allogenic virus-CTL infusion [ Time Frame: 24 weeks ]to evaluate the level of adverse events with CTCAE 4
- viral load change after CTL infusion [ Time Frame: 3 months ]The viral load response to the CTL infusion will be assessed by CMV/EBV specific PCR of peripheral blood everyday after infusion.
- The incidence of Ⅱ~Ⅳ°aGVHD within 30 days after the last dose of CTL infusion [ Time Frame: 1 months ]
- Reconstitution of antiviral immunity monitored by flow cytometry [ Time Frame: 6 months ]
- Number of patients with chronic GVHD [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159364
|Contact: Lung-Ji Chang, PhDemail@example.com|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD 86-13671121909 firstname.lastname@example.org|
|Principal Investigator:||Lung-Ji Chang, PhD||Shenzhen Geno-Immune Medical Institute|